Evaluating the safety and effectiveness of injectable gel with the ATP POUYA brand, for correcting nasolabial folds
Design
Phase II, before after clinical study
Settings and conduct
The study will be conducted in Center for research and training in skin diseases and leprosy. Before intervention face photography will be taken from participants using digital camera and Visioface camera for determination the severity of nasolabial folds, according to Allergan scale. Skin ultrasound also will perform on nasolabial folds. One intradermal injection with ATP POUYA will be performed on each nasolabial fold. The assessment will be repeated right after intervention and 2, 12 and 24 weeks later. Subjects’ satisfaction and adverse effect will be recorded in each follow up visit.
Participants/Inclusion and exclusion criteria
18 -65 years old men and women, with moderate to severe nasolabial folds, without any cosmetic facial procedures during last 3 months, with no allergy to gram positive bacteria protein, gel ingredients and no auto immune or immune deficiency diseases. No pregnant and lactating
Intervention groups
One injection with 1-2 cc ATP POUYA injectable gel in each nasolabial fold. ATP POUYA is a pure, disposable, viscose and transparent gel. The active ingredient of this product is stabilized sodium hyaluronic acid with non-animal origin.
Main outcome variables
Severity of nasolabial folds according to Allergan grading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N20
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the safety and effectiveness of injectable gel with the ATP POUYA brand, for correcting nasolabial folds
Public title
Safety and effectiveness assessment of ATP POUYA gel for nasolabial folds correction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 -65 years old men and women
Moderate to severe nasolabial folds based on Allergan criteria.
The opportunity to accompany the visit programs and study process.
Signing the informed consent form and agree to a 6-month follow-up.
Exclusion criteria:
Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment.
Cosmetic facial procedures (chemical peel, laser, radio frequency, dermabrasion, ablative or non-ablative procedures), Botox) in the lower 2/3 of the face, within 3 months prior to study entry
Planning to undergo any of these procedures at any time during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.115
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of nasolabial folds
Timepoint
Before intervention and right after intervention and 2, 12 and 24 weeks later
Method of measurement
5 scale Allergan photo numeric grading
Secondary outcomes
1
Description
Depth, area and volume of nasolabial fold
Timepoint
Before intervention and right after intervention and 2, 12 and 24 weeks later
Method of measurement
Visioface camera
2
Description
Thickness and density of dermis
Timepoint
Before intervention and right after intervention and 2, 12 and 24 weeks later
Method of measurement
Skin ultrasound
Intervention groups
1
Description
Intervention group: One injection with 1-2 cc ATP POUYA injectable gel in each nasolabial fold. ATP POUYA is a pure, disposable, viscose and transparent gel. The active ingredient of this product is stabilized sodium hyaluronic acid with non-animal origin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
415, Taleghani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pouya Teb Tools Company
Full name of responsible person
Nader Noshirvani Dizaji
Street address
Unit 8, No. 18, 2nd St., Yousef Abad
City
Tehran
Province
Tehran
Postal code
3738114789
Phone
+98 912 426 1875
Email
info@abzartebpouya.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pouya Teb Tools Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
MD and Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran University of Medical Sciences.
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
No 415, Taleqani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available